Rheumatoid arthritis (RA) is a chronic inflammatory, autoimmune condition in which the body’s immune system attacks its own joint tissues. It causes inflammation and pain, and eventually leads to joint damage and disability.
How Kevzara works
Kevzara is a human monoclonal antibody specifically targeting the alpha subunit of the IL-6R receptor. It works by blocking the binding of the IL-6 to its receptor, inhibiting inflammatory activity in people with RA. The drug is administered subcutaneously, or under the skin.
The drug was first studied as a treatment for RA in a clinical trial called MOBILITY (NCT01061736). This was a randomized, double-blind, placebo-controlled, multicenter study consisting of two parts: a dose-ranging Phase 2b and a confirmatory Phase 3 study. The aim was to evaluate the drug’s efficacy and safety in combination with methotrexate (MTX) in patients with RA who did not respond to MTX therapy.
In the Phase 2b part, the combination of five different doses of Kevzara plus MTX (active group) was tested and compared to a combination of placebo plus MTX (control group). In the active group, RA signs and symptoms declined by at least 20 percent after a 12-week period. Common side effects included non-serious infections, neutropenia (abnormally low levels of white blood cells called neutrophils), and liver function test abnormalities. The Phase 3 part also demonstrated that the Kevzara-MTX combo was effective in reducing RA signs and symptoms by week 24.
Another Phase 3 study, SARIL-RA-TARGET (NCT01709578), evaluated the safety and efficacy of two doses of Kevzara plus non-biologic disease modifying anti-rheumatic drugs (DMARDs). The Kevzara group saw that their RA signs and symptoms as well as physical function improved when compared to a placebo group. Two additional Phase 3 trials, SARIL-RA-EASY (NCT02057250) and SARIL-RA-ASCERTAIN (NCT01768572), also met their primary endpoints. SARIL-RA-EASY demonstrated the use of the autoinjector device, and SARIL-RA-ASCERTAIN, a calibrator study, the safety of two doses of Kevzara.
Regeneron and Sanofi submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for Kevzara in January 2016. But the FDA rejected the application and issued a complete response letter (CRL) highlighting manufacturing issues found in Sanofi’s facility. The rejection was unrelated to safety or efficacy issues. Both companies resubmitted a BLA and are now awaiting the FDA’s response.
Kevzara received Canadian approval in early 2017 to treat adults with moderate to severe RA who do not respond to or cannot tolerate one or more DMARDs. In Europe, Kevzara has received a favorable opinion from the European Medicines Agency (EMA). European Commission (EC) is expected to make a final decision on the companies’ Marketing Authorization Application in coming months.
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